10.07.06.02. 02 Definitions.. A. In this chapter, the following terms have the meanings indicated.. B. Terms Defined.. 1) "Action plan" means a written document that includes:. a) Specific measures to correct problems or areas of concerns;. b) Specific measures to address areas of system improvement;. c) Time frames for implementation of any specific measures; and. d) Title of responsible individual to monitor implementation and effectiveness.. 2) "Adverse event" means an unexpected occurrence

10.07.06.03. 03 Patient Safety Program.. A. General. On or before March 15, 2004, a hospital shall have in effect a patient safety program that meets the requirements of this chapter.B. Duties of the Hospital.. 1) The hospital shall identify an individual as patient safety coordinator who shall:. a) Coordinate patient safety activities;. b) Facilitate assessment and determination of the appropriate response to reported near-misses and adverse events related to patient care;

10.07.06.05. 05 Procedures for Level 1 and 2 Adverse Events and Certain Near-Misses.. A. When a level 1 or 2 adverse event, or a near-miss that warrants a root cause analysis occurs, the hospital shall:1) Provide immediate care to the patient;. 2) Identify any immediate corrective action to prevent reoccurrence;. 3) Identify and report the event in accordance with the hospital's reporting process;. 4) Complete a root cause analysis within 60 days of the time that the hospi

10.07.06.06. 06 Root Cause Analysis.. A. The hospital shall appoint an interdisciplinary root cause analysis team that shall include:. 1) Individuals who have knowledge of the event or near-miss;. 2) Representatives of hospital leadership; and. 3) Individuals with expertise in the subject matter of the event.. B. The root cause analysis team shall interview and permit participation of individuals who were directly involved in the event or near-miss and allow the individual to partic

10.07.06.07. 07 Procedures for Level 3 Adverse Events and Certain Near-Misses.. A. If the event is not a level 1 or 2 event or a near-miss that warrants a root cause analysis, the hospital shall conduct an evaluation of the event to determine any problem area and corrective action.B. All events shall be aggregated by type and level to determine any patterns or trends.. C. The hospital is encouraged to evaluate and trend all near-misses to determine any system problems.

10.07.06.08. 08 Information Sharing.. The patient safety program shall require that the quality assurance and other medical review committees share information and take any appropriate action concerning near-misses and adverse events.

10.07.06.09. 09 Reports to the Department.. A. A hospital shall report any level 1 adverse event to the Department within 5 days of the hospital's knowledge that the event occurred.B. A hospital shall submit the root cause analysis and action plan for the level 1 adverse event to the Department within 60 days of the hospital's knowledge of the occurrence.C. Any root cause analysis and any other medical review committee information submitted to the Department and the identity of

10.07.06.11. 11 Patient Complaint Program.. A. In accordance with this regulation, the patient safety program shall include a formal written program for addressing patient complaints.B. The hospital shall provide patients with information regarding the hospital's patient complaint program including:1) The name of the hospital's representative that the patient may contact if the patient wishes to make a complaint; and2) The hospital representative's phone number or address..

10.07.06.12. 12 Interhospital Notification Of Level 1 or Level 2 Adverse Events.. A. A hospital that admits a patient with a condition resulting from a level 1 or level 2 adverse event that the hospital perceives may be related to care that was provided at another Maryland hospital and that appears to be unknown to the other hospital at the time of discharge shall notify and provide any necessary information to the appropriate medical review committee at the hospital where the

10.07.06.14. 14 New Program Documentation.. A. On or before March 15, 2004, the hospital shall send to the Secretary a written description of its patient safety program that includes:1) The name of the patient safety coordinator;. 2) The board policy statement relevant to patient safety activities including the process to review the hospital's patient safety program and to determine the effectiveness of the hospital's patient safety program;

10.07.06.15. 15 Plan of Correction.. A. If the Department notifies a hospital that the patient safety program of the hospital does not meet the requirements of this chapter, the hospital shall submit a plan indicating the steps the hospital shall take to meet the requirements of this chapter.B. The plan shall be sent to the Secretary within 10 days after the Department notifies the hospital that the hospital does not meet the requirements of this chapter.

10.07.06.16. 16 Penalties.. If a hospital fails to have in effect a patient safety program in accordance with this chapter, then the Secretary may impose on the hospital the following penalties:A. Revocation of the hospital's license; or. B. A fine of $500 for each day that the hospital is in violation of this chapter..